MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.The investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The steerable guide catheter is filed under a separate medwatch report number.

Event Description

This report is filed since the stopcock had unexpectedly separated from the device.It was reported that on (b)(6) 2022, the patient presented with functional mitral regurgitation (mr) grade 4.A steerable guide catheter (sgc) was advanced.Once in position, air bubbles were observed in the heart anatomy and the sgc lost fluid column.The sgc was removed from the stabilizer and re-positioned below the patient.Aspiration was performed and the same sgc was left in position.The mitraclip delivery system was prepared.During preparation and before patient use, the stopcock had unexpectedly separated from the device.The same stopcock was placed back on the device.The device was successfully re-flushed without further issues.The mitraclip was successfully implanted without any issue or malfunction, reducing the mr to grade 1.Following clip implantation, air was observed once again in the anatomy.The patient had become hypotensive (systolic blood pressure in the 50¿s), compressions were performed, and medications were provided.Reportedly, the compressions were performed due to the hypotension.There was no cardiac arrest or myocardial infarction noted.There was no leak, or device issue regarding the mitraclip device once in the anatomy.The mitraclip device had been successfully re-prepped before insertion into the anatomy.The air was thought to be residual from the steerable guide catheter, although this was unable to be confirmed.The patient stabilized and was sent to the intensive care unit for further monitoring.On (b)(6) 2022 a brain mri was performed.Small lacunar infarct involving the superior right cerebellar hemisphere was noted along with chronic microvascular ischemic white matter disease and chronic hypertensive encephalopathy.Reportedly, the patient is doing well.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of hypotension, embolism and cerebrovascular accident as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on available information and without the device to analyze, a cause of the reported loose or intermittent connection (stopcock to luer) could not be determined.A cause of the reported air embolism could not be determined.The cause of the reported hypotension and cerebrovascular accident (lacunar infarct) also could not be determined.The reported medication required and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.H1: type of reportable event h6: health effect - clinical code 4582 - removed.H6: health effect - impact code 2199 - removed.

Event Description

Subsequent to the previous medwatch report, the additional information was received on (b)(6) 2022: per physician, it is unknown what caused the air bubbles later in the procedure.Per physician, it is unknown if the steerable guide catheter or mitraclip were related to the air late in the procedure.It is also unknown if the small lacunar infarct was a cerebral vascular accident.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13502226
• MDR Text Key: 288786370
• Report Number: 2024168-2022-01378
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 11007R251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 87 KG